KR101223382B1 - Joining foils with laser for sterile lancets - Google Patents

Abstract

Providing a tape comprising a plurality of lancets comprising a lancet tip and a lancet body, covering at least the lancet tip with at least one foil constituting at least partially overlapping the first and second portions; Sealing at least one foil with a laser beam at at least edges of the first and second portions of the portion.

Description

JOINING FOILS WITH LASER FOR STERILE LANCETS}

The present invention generally relates to a process for sealing a biosensor, a test element, or a medical device such as a poke device such as a lancet or a needle.

Medical devices such as test elements or biosensors for measuring the presence or concentration of selected analytes in test samples are known. This applies to stab elements such as needles, lancets or knives. Typically, such medical devices are packaged and stored in a sterile environment. In particular, the prick element must remain sterile until used. There are many different ways in the prior art to describe how lancets are packaged in a sterile environment.

Document US 2004/0163987 describes a sealing process for medical devices such as lancets. Here, the sealing is achieved using adhesives sensitive to heat or pressure.

Application EP 1508304 also describes pressure sensitive adhesives that can be activated by heat or are pressure sensitive. In general, the manufacturing process for packaged lancets is carried out by lamination techniques. Procedures such as screen printing, slot coating are mentioned for the packaging of lancets. The adhesive material may be lined or punched by the laser prior to this lamination process.

In another patent application US 2006092281, the sealing of lancets, which may be combined in test elements, is also described by adhesive or heat sealing.

All manufacturing processes have the disadvantage that additional materials such as adhesives are used to bond the packaging material surrounding the lancet. This additional material may contaminate the lancet. A further disadvantage of tack or heat sealing is the fact that in this process only a laminar sealing or bonding process is achieved. This layering process requires a lot of space surrounding the lancet, which is particularly disadvantageous when the lancet must be stored in a magazine. The sealing line cannot be narrowed because when the sealing line is narrowed the sealing process is not complete and the sterilization environment for the lancet is not achieved. In addition, automatic removal of the sterile packaging can be achieved while using the system by sticking the lancet into the sterile lid. However, needle tips are often damaged by pushing the needle into such packaging as described above. In particular, if a small, thin lancet is used for the painless poke step, damage to the needle tip occurs well.

Thus, there is a need for a reproducible and reliable process that seals the lancet to enable efficient storage of the lancet and enables automatic opening of the vault to facilitate handling of the lancet with the lancing device without the need for user interaction. There is this.

In order to overcome the negative aspects associated with processes known in the art, providing a tape comprising a plurality of lancets comprising a lancet tip and a lancet body, at least partially overlapping the first and second portions Covering at least one lancet tip with at least one foil, and sealing at least one foil with a laser beam, preferably at least at the edges of the first and second portions of the overlaid portion; The manufacturing process of this is described.

The process describes, for example, a manufacturing process for lancets packaged in blister packs. The lancet can be used in a lancing device having a drive unit capable of automatically connecting to the lancet of the reservoir and accelerating the lancet for execution of the prick process. Such lancing devices are typically used by patients themselves who collect blood several times a day to measure analytes such as blood glucose in hospitals or with home monitoring systems. In order to conveniently handle the lancing device, it is desirable to store several lancets in the system so that the user does not have to change the lancets by hand after the stab step. Therefore, the storage of a modern lancing system typically stores multiple lancets and is automatically handled by the system itself. In particular, the lancet is automatically connected to the drive unit of the lancing device and driven out of the reservoir to execute the prick step. The lancet is then preferably stored inside the housing of the device, after which the lancet is separated from the drive unit so that a new lancet can be connected to the drive unit if the patient performs the next prick process. Automatic handling also includes removing the sterile packaging, in particular so that the needle tip is released from the sterile cover. However, in order to avoid contamination or germ infection, the lancet should be stored in a sterile environment until the lancet is used by the patient after the manufacturing process of the lancet depot. This means that the reservoir in which the plurality of lancets are stored must be stable in order to maintain the lancet sterilization environment for a long time, such as several years. Therefore, the packaging must meet special requirements, especially for the materials that make up the sterilizing lid and for the manufacturing process in which the lid is to be sealed. As a result, metal foils are used, for example, to seal the lancet in an airtight environment. However, for the automatic removal of the sterilizing cover, the needle is driven simply through the foil as described in the prior art and then damaged by the metal foil, and also the plastic foil is for example bliss as described in DE 2803345. It is also damaged when used in a pack. Such blister packs are made by assembling two foils together and sealing the foils in a hot melting process. As a result, the needle is surrounded by a welded seam. If the needle is then pushed through the foil, the needle is driven through the weld seam, whereby the needle tip can be damaged even if a soft plastic tip is used.

Optionally, prior art systems include a cap removal mechanism that removes the cap before the prick step is performed. Such a mechanism is unfortunately usually complicated, so a compact and small lancing device cannot be realized.

Originally, the claimed manufacturing process does not use two separate foils, which are assembled together to allow the weld seam to enclose the needle, as realized in prior art systems. Compared to the prior art, the process of the present invention uses a foil that is folded around the needle tip such that the first and second portions of the foil are at least partially overlapped in the region of the lancet tip. In particular, the sealing process does not apply to this end of the foil with a lancet tip. This means that the area of the foil through which the needle passes during the pricking process does not have welded seams. Therefore, the needle tip need not be driven while passing through the weld seam and damage can be avoided. After folding the foil around the needle tip, the foil can be preferably sealed by a laser beam such that the first and second portions are joined together.

However, when the foil is folded as above, the sealing process sometimes becomes important. In particular, a loop can be made by the folding process so that the part of the foil is no longer in intimate contact. In particular, the folding process of the foil has the risk that the cavity remains at this end where the foil is folded and the cavity remains in the packaging after the sealing process, especially at the welded seam. If so, depending on the size of the cavity, the sterilization environment can no longer be guaranteed.

Therefore, another aspect of the present invention provides a tape comprising a plurality of lancets comprising a lancet tip and a lancet body, at least one lancet with at least one foil constituting at least partially overlapping the first and second portions. Covering the tip, the foil is pressed against the lancet in a first direction, and also a force is applied to the foil such that at least partly the force is applied in a second direction perpendicular to the first direction, such that at least one portion of the foil is opposite the lancet tip Superimpose the first and second portions of the foil so as to be flat toward the end of the lancet in the seal, sealing at least one foil with preferably a laser beam at at least the edges of the first and second portions of the overlapped portion This improves the above process.

As a result, a force is applied to the foil before the portions of the foil are sealed together. On the other hand, the force presses the foil onto the lancet, so that some of the foil is in close contact with each other. On the other hand, the force also acts in a direction perpendicular to the pressing direction to flatten the foil and pull the foil towards the rear end of the lancet opposite the lancet tip. As a result, part of the foil can be joined together without a loop, especially in the area where the foil is folded around the lancet tip. Preferably, this is realized by a contactless process, for example by means of air pressure directed to the foil in a direction between 0 ° and 90 ° so that a force can be applied directly to the foil and in a direction perpendicular thereto. In a preferred embodiment, an air nozzle that is adjustable at a particular angle relative to the foil is used. In addition, the pressure of the air can be adjusted and is preferably adjustable as a function of the angle setting. Nevertheless, other processes may also be considered for applying the force to the foil. For example, mechanical means for pushing or pulling the foil to the rear end of the needle on the opposite side of the needle tip as also known in the art may also be used.

Another aspect of the present invention is to accurately position the lancet relative to the foil such that the position of the lancet within the packaging is reproducible.

The process of manufacturing a packaged lancet includes providing a metal sheet in which a plurality of lancets, including a lancet tip and a lancet body, are secured through at least one predetermined fracture point. Position the metal sheet relative to the tape comprising at least one foil covering at least the lancet tip, place the at least one lancet over the tape and press the at least one lancet to the tape to break at least one break point and the lancet Comprises the step of no longer connecting with the metal sheet. Before, during, or after securing the lancet to the tape, the metal sheet is removed and at least partially covered with at least partially overlapping the lancet tip with a foil constituting the first and second portions, the foil of the overlapping portion Sealing at least one foil, preferably with a laser beam, at at least the edges of the first and second portions.

For example, when the lancet is used in the lancing device as described above, it is important to position the lancet correctly. In particular, the lancet should be located in the reservoir in a manner defined relative to the drive unit so that the connecting element connecting the lancet with the drive unit can be connected to the lancet accurately in a defined and reproducible manner. As a result, the position of the lancet within the system can be accurately determined and precise control of the depth of the prick ensures a painless pricking process. Therefore, reproducible positioning of the lancet within the foil must be ensured even during the manufacturing process. This means that lancets, typically up to 1 cm in length, must be handled in an accurate manner during the mass production process. Originally, the problem is solved by providing a metal sheet comprising a lancet construct. Preferably, the lancet construct is made by an etching process that can be easily realized with low tolerances. Of course, other processes are also possible for cutting the lancet construct from the metal sheet. For example, a laser cutting process or other processes known in the art are possible. However, since the lancet construct is not cut completely in the metal sheet and is still connected to the metal sheet through a predetermined break point, the lancet is continuously positioned in a manner defined relative to the dimension of the metal sheet. Therefore, a continuous metal sheet that must be positioned in a relatively defined manner relative to the tape, rather than a single lancet, must be handled and positioned in the foil at least to cover the lancet tip. As is known to those skilled in the art, the exact location of the two tapes can be easily realized even in mass production processes. The metal sheet is then placed on a tape, which is preferably a plastic foil for covering at least the lancet tip. At this time, the lancet is continuously connected to the metal sheet lying on the plastic foil, after which the lancet is pressed downward in the tape and is thus fixed to the tape by, for example, a hot melting process. At the same time, before or after that, the lancet is separated from the metal sheet by breaking the predetermined breaking point. After the lancet is secured to the tape and separated from the metal sheet, the metal sheet can be removed. Thereafter, at least the tip of the lancet is covered by constituting the first and second portions of the tape at least partially overlapped. Finally, the foil is sealed at the edges of the first and second portions of the overlapped portion, so that the lancet can be sealed in a sterile environment. Therefore, a force is preferably applied to the foil before the edge of the foil is sealed, so that the foil is flattened towards the rear end of the needle opposite the needle tip, so that the first and second portions of the foil They overlap each other and stick together. The first and second portions of the foil are now sealed in an airtight manner to meet the requirements for sterile packaging of the lancet. Also in a preferred process, a laser beam is used for the sealing step.

Preferably the process of sealing at least one foil surrounding the tip of the lancet with a laser beam is also a non-contact process. By this process even complex three-dimensional objects can be sealed. An example of such an object is a lancet surrounded by a foil. Since there is no more material in contact with the material surrounding the lancet, no contamination of the foil or lancet occurs. In contrast, if a laser is applied to the foil and substrate during the laser sealing process, the sterilization environment of the surfaces contacted by the laser is also guaranteed. When the laser is focused on the overlapping portion of the at least one foil, a sealing line is constructed between the two layers of the foil (s). In the laser sealing process, since the expansion of the laser beam is very small (in the dimension of the optical wavelength), the dimension of the sealing line is reduced in comparison with other sealing techniques. Although the sealing process of the foil is achieved with a layered laser sealing process, the dimension of the sealing line is much smaller than the dimension of the sealing line of the sealing treated by adhesive or heat sealing described in the prior art. Another advantage of the laser sealing process is that it ensures that the foil is sealed in a hermetic manner. This guarantee is achieved by sufficient energy input of the laser of the foil to melt the foil in a uniform and reproducible manner. Nevertheless, other sealing processes as known in the art are also possible, for example as thermal melting processes. However, in combination with the process of the present invention, the laser sealing process is particularly preferred. For example, the laser sealing process can be easily controlled. There are at least three elements that need to be controlled.

Laser power concentrated in specific areas

-Uniformity of foil

Proximity of the foil at the sealing site

In a laser sealing process, a foil may be used as a material meltable by a laser, where the foil is melted by a laser, which melts the bond between the two foil layers without cutting or breaking the foil. Some materials used as foil materials are, for example, PET (polyester) foils, PP (polypropylene), PE (polyethylene), cyclic polyolefins (such as TOPAS®), PVAC (polyvinylacetate), PMMA (polymethylmetha) Acrylate), or PA (polyamide). Despite the fact that the foil material must be meltable to the energy of the laser without being destroyed by this process, there is no limit to the foil material to be used in this process.

It is possible to use different materials for the first part and the second part of the foil. At least one material must be meltable by the light of the laser. The other part must interact with the molten part, with stable interaction of the two parts being achieved. In a preferred embodiment, the two parts consist of the same material.

If the two parts belong to one foil, the third part is also part of the foil. In this preferred embodiment, the third portion defines an edge between the first portion and the second portion of the nesting formed by the foil. If only one foil is used to surround the lancet, the process may be achieved in a very effective way in time and material. A process with only one foil is one step less than a process in which two different foils are used. Since only one feed mechanism should be activated and the lancet and foil alignment must be achieved only once, enclosing the lancet with only one foil can be achieved much more easily than enclosing with more than one foil.

The process of sealing at least one foil at at least the edges of the first and second portions of the overlaid portion may be accomplished by different kinds of lasers. The energy of the laser beam should be suitable for the melting characteristics of at least one foil. Examples of lasers are:

a) Nd: YAG,

b) CO ₂ ,

c) diode laser,

d) fiber laser.

Such lasers have different properties that can be used for different purposes in such sealing and cutting processes. Nd: YAG lasers have high laser quality due to high stability, small laser spots (about 10-50 μm), and may be implemented via fiber optic cables. Such lasers may be used continuously and in batch mode, where typically 20 to 600 W of power is used, but the laser may also beam at a power of 5 kW.

CO ₂ lasers are less quality because the laser spot can be concentrated to about 150-350 μm. In addition, CO ₂ lasers can be used in continuous mode, especially for melting of polymers, in the power range from 10 to 600 W to 5 kW. The beam is typically focused on the substrate through a mirror optic.

Diode lasers have the advantage of being constructed or integrated in very scaled systems because of their small dimensions (several centimeters). The laser diode constitutes an efficient beam source in the infrared region, whose efficiency is about 50% in the infrared region. One laser diode may reach about 100 W of power, but may be connected to another diode to reach the kilowatt region.

At least the tip of the lancet is surrounded by at least one foil. During the sealing process, the laser beam is guided past at least the edge of the overlapping portion of the at least one foil. The overlaid foil may be in the form of a circle, triangle, square or rectangle and oval and combinations thereof. In a preferred embodiment, the shape of the foil is rectangular. The dimensions of the first and second portions of the foil (s) may be the same, but may also differ in size. In a preferred embodiment, the dimensions of the first part and the second part are the same.

Since the dimensions of the sealing line are very small, it is possible to enclose the lancet at least in the region of the lancet tip in very narrow spaces. The result is an efficient process in space and material, allowing the storage of many lancets in a small storage facility.

In another preferred embodiment, the lancet is sealed between two portions of the at least one foil with the lancet body. Before the lancet is placed in or on the tape, the lancet body may be at least partially covered with a meltable adhesive. With this meltable adhesive, the lancet may be at least partially secured to the substrate or tape. By this fixation it is also possible to avoid unwanted destruction of the foil before using the lancet. In such embodiments, the lancet tip may be movable in a sealed environment in a stored form without the risk of accidentally breaking the foil.

In a combination of a prick device and lancet, the lancet may be used to pierce or pierce the skin of the patient for the generation of body fluids. Body fluids may be collected in the form of interstitial fluid, serum, plasma or whole blood. During use of the lancet in the prick apparatus, at least the lancet tip is forced to go through the foil. Since the foil is very small in thickness, the lancet tip will not become dull or contaminated by cutting the foil. After generating a sample of the bodily fluid, the sample may be delivered to a test element incorporating a reagent that can react with the analyte of the sample. Such analytes may be any molecule of the sample, such as glucose, cholesterol or other substances of body fluids.

The prick device and / or test element may be part of a device capable of analyzing the test element to obtain results for the concentration of the analyte. It may be an optical, electrochemical, amperometric, potentiometric or any other detection method known in the art for the detection of analytes in body fluids.

Such prick devices, test elements and devices are known in the art and need not be described in detail to those skilled in the art. Examples of stabbing devices are shown in US 5,879,311, US 6,866,675 and US 5,857,983, examples of test elements in US 4,999,582, US 6,506,575, US 6,036,919 and EP 0230472, and examples of instruments are in EP 591226. Lancets and their production procedures are known, for example, from EP 0565970.

The energy input required to sufficiently melt the foil in a short time range of one thousandth of a second depends on the melting point and thickness of the at least one foil. The thickness of the foil may be 1 μm to 100 μm, preferably 5 μm to 30 μm, and most preferably about 10 μm. This process may be achieved at a speed of about 5 m / min. During the process of covering the lancet and the substrate with the foil (s), the foil may be bent in one or two dimensions of the foil layer. By bending this foil, the sheath of the lancet is prestressed so that it can be easily broken by the lancet during the lancing process. By the prestressed state of the foil, the cut edges of the foil will be away from the lancet tip during or after the cutting process, and by this prestressing the material of the lancet may be less contaminated.

During the sealing process, the nested portion of the at least one foil of the first and second portions should be very close to each other, preferably at least in contact with each other in the portion where it is to be sealed together. The foil may be held close to the substrate by adhesive force. This adhesion may vary depending on the choice of material. This adhesion is a result of the surface properties of the foil. Electrostatically loaded materials increase adhesion. Procedures for imparting electrostatic force to the surface of a material are known in the art. This adhesion may be the strength at which the substrate is hermetically covered with respect to the foil. This adhesion may also occur between two portions of the foil covering the lancet lying on or on the substrate or tape.

Another option for keeping the foil tight around the lancet and / or the substrate is to apply a vacuum or pressure during the process of covering the foil around the lancet and / or the substrate. By this process, the parts of the foil are laminated to each other. This may also be achieved by a roll guiding the foil with the lancet and the substrate.

By this optimized process, at least some of the first and second portions of the at least one foil are melted by the laser beam during the sealing process. The dimensions of the molten portion depend on the width of the laser beam and the capacity of the foil to absorb the light energy of the laser. The dimension of the melt line may be from 0.05 mm to several millimeters.

During the process, at least one foil may be cut by a sealing process. The sealing process may also be used to unify the lancet when the lancet is produced, for example, in a web like manner, by etching or other techniques. As an example for the continuous process, for example, the laser power of the laser diode (940 nm) may be 20 W with the spot range used being 3 mm. This may vary over a wide range depending on the material used and the speed of the process.

An example of a web may be a flat steel foil where at least the lancet tip is etched or stamped. Such steel foils may have a thickness between 0.07 mm and 1 mm. The lancet tip may be sealed by the foil before, after or during the singulation step. This depends on the purpose of the laser treatment. If the web is used in storage form, the lancet is not unified before use, or the unification step is not achieved by the laser and the energy of the laser is only applied to melt at least one foil without cutting the foil.

In a preferred embodiment, the sealing and unification of the lancet tip is carried out in one process step by means of a laser. In this process, because the web, for example steel foil, must be cut as well as the seal, the laser energy must be greater here.

In one embodiment, one foil covers the first side of the lancet to constitute the first portion, and a second foil covers the second side of the lancet to constitute the second portion. These two foils may contain the same components or may be composed of different materials.

In another embodiment, at least one of the two portions of the at least one foil also covers the body of the lancet.

The body of at least one lancet may be fixed to the foil. This fixing may be performed by another heat source such as a laser or hot stamp.

When the foil is heated in the lancet body, the foil is fixed to the lancet body because the foil melts even in small portions while in contact with the lancet body. In such embodiments, the material of the foil and the lancet body may be selected such that they bond to each other when the foil is melted. During this process, the lancet body is preferably not melted by the applied heat.

In another embodiment, the first portion of the foil covers the first side of the lancet, the second portion covers the second side of the lancet, and the first portion and the second portion are in a third portion in front of the lancet tip. Is connected by. These three parts may belong to one foil which overlaps with at least a part of the lancet. The first and second portions can cover one different side of each of the lengths of the lancet, and the third portion is combined with these two portions by surrounding the lancet tip. The material and / or thickness of the foil portion may be different in these three portions, but preferably the material of the three foil portions may be the same and the thickness may be the same.

Sealing of the foil may be accomplished by a layered laser sealing process. In this layered laser sealing process, laser sealing with a wider sealing line is achieved than the sealing by a highly concentrated laser process. Layered laser sealing processes are typically achieved by CO ₂ lasers or diode lasers.

The lancet may be made of any material such as a metal or a mixture of metals, polymers, ceramics or other suitable materials that may constitute a sharp lancet tip that is strong enough to enter the patient's skin without deformation, bending or breaking. If the lancet is made, for example in the form of a metal web or tape, the lancet tip is formed in an etching process, and the plurality of lancets may be separated by a laser beam during the sealing process. In this process, the power of the laser must be large enough to cut a metal sheet of 0.07-1 mm. The foil layer is also cut while the metal is being cut, by which the foil is fixed to the metal edge of the lancet body.

During or before the sealing and / or cutting process, a plurality of lancets may be disposed on the substrate. The material of the substrate may vary. The substrate may be another foil or web of different tissue such as polyester, polypropylene, polyethylene, cyclic polyolefin (eg, TOPAS?), Polymethylmethacrylate, polyvinylacetate or polyamide. Examples of other materials are given in US 20050245845. For storage, the plurality of lancets may be secured to a tape that is flexible enough to be wound into a roll or coil.

The lancet may be stored in different ways after its unification. In one embodiment, the lancet is disposed in the web such that each lancet can be driven individually. The lancet may be combined with the test element before or after placing the lancet in the web. In other embodiments, the test element may be disposed between lancets.

The different form of storing the united lancet is for example stacking. Other storage forms of lancets or lancets integrated with test elements are also possible. There are several alternatives known in the art.

After or during the cutting and / or sealing process, the lancet may be sterilized. Such sterilization may be accomplished, for example, by heat or radiation or other known sterilization procedures.

In addition, the lancet body may be attached to the test element. This test element preferably has a test plate to which a fluid sample, such as blood, is applied. In combination with lancets, these test elements may also be in direct contact with the punctured tissue, which may draw blood from the test plate. An example of a lancet connected to a test element is shown in US 20060079810. Other possibilities for combining test elements and lancets are described in US Pat. No. 6,866,675. Here, the lancet further incorporates capillary channels or other structures to pierce the patient's skin and then collect fluid. Such blood may then be delivered to test elements that are in direct contact with the capillary channel or stored separately.

Trials may incorporate chemicals such as enzymes that interact with the analyte to determine the concentration of the analyte in the sample.

The present invention also described,

a. A lancet having a lancet tip and a lancet body, and

b. At least one foil covering at least a tip of the lancet and at least partially overlapping each other, constituting a first portion and a second portion,

The foil is sealed by laser treatment of at least an edge comprised by two partially overlapped portions of the at least one foil, after being overlaid with at least a portion of the lancet, to maintain at least the lancet tip in a closed environment It includes a device for collecting.

Such a device may be processed by the above process.

When the device is attached to a further test element, at least the lancet is movable in the foil. This allows the lancet to move individually with respect to the test element and the foil. In order to move the lancet through the foil, the device with the test element and / or the lancet may be arranged in a device that may incorporate a lancet driver. The device may also incorporate a test element driver, which may be the same as the lancet driver, and may additionally include reading equipment for reading the test element. Such reading may give different results depending on the specification of the test element.

An example of the production process by laser sealing is as follows.

Production process of lancet label master:

Polyethylenetelephthalate (PET) foil having a thickness of 19 µm (Dupont Melixex S?) Constitutes a tape substrate. The surface of the foil was, for example, 20 g of Vinnapas B500 / 20VL in toluene by means of a doctor blade of a laminator. Coating with a mixture of (manufactured by Wacker AG Burghausen). The gap of the doctor blade is about 120 μm and the tape speed is 0.5 m / min. Drying of the coating is carried out with warm air at about 50 ° C. The thickness of the coating after drying is about 12 μm. Vinnapas coating acts as a hot melt coating in the following steps.

Stainless steel 304, 76 μm thick, 2.25 mm wide and 4.56 mm long, produced by etching? The flat lancet is placed on the coated surface of the PET tape at precise intervals and fixed to the tape by heating only the lancet body with a hot stamp or laser pulse to activate the hot melt coating.

Bidirectionally pulled PET foil with 6 μm thickness (Mitsubishi Polyester Film, Hostaphan RN? From Wiesbaden) is applied smoothly to the lancet tape with the use of soft rolls. Excess of foil is CO ₂ laser Starshape 300 C? It is cut at the edge of the tape by Ronin. The adjusting device of the laser is a 200 mm lens, the speed of the reflector is 1000 mm / sec and the power is 120 parts = 31 J / m. The cut width is about 300 μm.

The tapes joined together have a DuroTak? Type 387-2825 / 87-285 (National Starch B.V.) is laminated to a transfer sticky foil. This adhesive delivery foil consists of a release-liner and an adhesive film of 20 μm. After lamination, the tape is wound on a roll and sterilized by, for example, spinning.

Process for producing lancet label from the master:

CO ₂ laser Starshape 300C? With Ronin, the lancet label is cut from the tape. Each label may include one, two or three lancets in a row. The distance of the widest part of the lancet to the cutting line is at least 0.5 mm. The width of the label is at least 1 mm wider than the length of the lancet. The remaining material not included in the label is removed. It produces a liner with a self-adhesive lancet label.

Production process of lancet tape:

The resulting foil of the lancet tape was a bidirectional pulled PET foil with a thickness of 12 μm (Mitsubishi Polyester Film, Hostaphan RN? Of Wiesbaden). A single lancet label is delivered to this PET transport foil by precise positioning on the foil. The accuracy of this transmission is at least +/- 1/10 mm. This lancet tape is CO ₂ laser Starshape 300C? It will be cut into three lancet tapes having a width of 5.0 mm by Ronin. The end of the lancet body is disposed about 0.2 mm from the cutting edge.

By this process, very fast sealing may be achieved with very accurate and reproducible sealing results. The quality of the sealing process is more accurate and more reproducible than the process of hot bonding and hot stamping.

1 is a perspective view of a lancet reservoir in which a foil surrounds at least the tip of the lancet;
2 shows a sealed lancet cut by a laser in which all edges are sealed by laser cutting.
3 shows a lancet in or on a substrate surrounded by a sealing foil in which the foil is bonded to the substrate by laser welding.
4 shows a substrate in the form of a tape, in which a plurality of lancets are disposed in or on and at least partially overlapped by a sealing foil.
5 shows a process of unifying lancet labels on a tape with a laser.
6 illustrates the transfer of a unified lancet label from lancet tape to another tape.
FIG. 7 shows combining the lancet and test element sealed together by laser sealing between at least one foil into a lancet integrated test element (LIT).

1 shows a lancet tape 3 in which a plurality of lancets 2 are located on the lancet tape 3 or are part of the lancet tape 3. Preferably, the lancet 2 is located in the same direction both on the tape 3 or in the tape 3. The lancet tip 2a of the lancet 2 should be reachable from at least one side of the tape 3. This lancet tape 3 is covered by a foil 5 which is nested next to the lancet tip 2a on both sides of the tape. On one side of the lancet tape 3, this foil 5 constitutes the first part 5a of the foil. On the opposite side of the lancet tape 3, the second part 5b of the foil 5 is arranged. When the lancet tape 3 is covered by only one foil 5, this foil 5 overlaps the foil 5 in at least the region of the lancet tip 2a at one edge of the lancet tape 3. The 3rd part 5c comprised by this is comprised. If the two parts 5a and 5b of the foil 5 are constituted by two separate foils, the third part 5c is covered by the overlapping portions of the two foils extending beyond the substrate 3a. It is composed. When the two foils are melted together in the sealing process in the form of a sealing line, this third portion 5c is formed. During the sealing process of the label 1 in which two foils are used, the overlapping portion of the foil beyond the substrate 3a is cut during the sealing process, the cutting fixing, or the combination process of sealing and cutting. At least the tip 2a of the lancet 2 is located between the overlapping portions 5a and 5b of the foil 5. In the embodiment shown, the entire lancet 2 is covered by the first part 5a and the second part 5b of the foil 5.

The lancet 2 can be unified from this lancet tape 3 in the form of a lancet label 1 by cutting the lancet tape 3 with a laser 4. After the at least one foil and the lancet tip 2a are overlaid, the three parts 5a, 5b and 5c of the foil are laser sealed together by a CO ₂ or Nd: YAG laser. After this sealing process, at least the lancet tip 2a is sealed by the foil portions 5a, 5b, 5c.

2 shows a lancet label 1 incorporating a portion of the lancet tape 3 in the form of a substrate 3a. On this substrate 3a or on this substrate 3a, the lancet 2 is located. In this case, the shape of the lancet label 1 is rectangular, but the shape of this lancet label 1 is not limited. In addition, the lancet level 1 may have a round shape or an ellipse shape. During the singulation process, the laser 4 cuts the foil 5 together with the substrate 3a of the lancet tape 3. The foil is melted by this process and clings to the substrate 3a so that the lancet label 1 is sealed at the cutting edges 8 and 9. The lancet 2 is surrounded by three parts 5a, 5b and 5c in a sealed state. The process not shown in FIG. 1 and FIG. 2 shows that the lancet 2 in the cavity 10 constituted by the substrate 3a of the lancet tape 3 when the lancet 2 is positioned on the lancet tape 3. Is the sealing of. This cavity 10 is constructed in the lancet tape 3 by cutting so that the lancet 2 can be placed in this cavity before the lancet label 1 is formed by the laser cutting process. During or before the cutting process shown in FIG. 1, the cavity 10 is sealed by a laser 4 surrounding the cavity 10 in which the laser beam 4 is arranged. By this process, the foil 5 can be melted in the substrate 3a so that the lancet 2 can be kept in the cavity 10 in a sterile state. For this sealing process, the laser power of the laser 4 is less than the power for the cutting process shown in FIG. After the sealing process, at least the lancet 2 is surrounded by three parts 5a, 5b, 5c of the foil 5. The sealing line 12 may be adjusted to the shape of the cavity 10. This sealing process may be inspected by an optical or pyrometric process. This may be done, for example, by a CCD camera, a thermo camera or a pyromerter.

3, 3a and 4, two different processes are shown for covering the lancet label 1 or the lancet tape 3 with the foil 5. In FIG. 3, each lancet label 1 is already cut and unified. The cut lancet label 1 is positioned above the foil 5, and the cavity 10 is filled with the lancet 2 before the foil 5 is folded across the front edge 11 of the label 1. Thereafter, the foil 5 is folded so that the foil portions 5a and 5b are stacked. As shown in FIG. 3A, a loop 5c is created from the folding process, in which the foil is folded and this area surrounds the lancet tip. In order to avoid such a loop, the air pressure P is applied to the foil so that the foil is pressed on the lancet label 1, and also in the direction perpendicular to the direction in which the force by the air pressure is pressed so that the foil is the lancet main body. Make sure that it is flattened toward the rear end of and closely aligned with the lancet label. In particular, the force is exerted at a defined angle α relative to the tape. The foil is then fixed to the substrate 3a by, for example, laser welding. Since the dimensions of the laser are small even in the welding process, the lancet is not affected by this welding process. Thus, the lancet is not fixed by this welding process. After this welding process, the foil 5 may be sealed at least at the edge 10d, which keeps the lancet tip 2a in a sterile state by sealing the cavity 10 by laser sealing. This welding and sealing process may be performed by a diode laser having a wavelength of 940 nm. Furthermore, the lancet body, preferably excluding the lancet tip, may also be secured to the tape by additional steps of the welding process known to those skilled in the art.

In a preferred sealing process, the cavity 10 is additionally sealed at its edges 10a, 10b, 10c, 10d around the lancet 2. Accordingly, the lancet 2 is surrounded by at least four sealing lines (not shown), and at least one sealing line is formed only at the foil portions 5a and 5b at the edge 10d, while the other sealing line is at the edge ( It is formed between the foil 5 and the substrate 3a in 10a, 10b, 10c. The first part 5a and the second part 5b together with the third part 5c of the foil 5, depending on the position of the sealing line constituted by the foil parts 5a and 5b at the edge 10d. In addition to the portion of the small channel may be configured. If the sealing line is not disposed directly at the edge 10d but closer to the lancet tip 2a so that the first portion 5a and the second portion 5b are included in the sealing line, the sealing line is at the edge 10d. The third part 5c of the foil 5 is separated from the rest of the foil 5 by constructing such a channel. This channel ensures a sealed separation of the internal lancet 2 and the sealed cavity 10 after the sealing process of the cavity 10. It is also possible to place the sealing line at the edge 10d to achieve the sealed cavity 10. Here, the sealing line incorporates only the third part of the foil.

The lancet body 2b may integrate the element 2c to cooperate with a system component such as a drive or a penetrating device. This element 2c may have different shapes, such as holes, cavities, champs or hooks or guide members. Such elements may be in contact with a plunger of a drive device or device (not shown in the figure). By this interaction of the lancet 2 with the drive device, the lancet 2 may be moved out of the pocket or cavity 10 by breaking the foil 5 in the third part 5c with the lancet tip 2a. . By this driving process of the lancet 2, the parts of the other parts 5a and 5b may also be destroyed. In order for the lancet 2 to have no material when it reaches the skin of the user, it is preferable that the broken portion of the foil is pushed out of the cavity 10 after the lancet is driven.

Alternatively, the foil may be peeled off, for example by a tweezers-type gripper while using the lancet 2 in a prick apparatus (not shown).

In FIG. 4, the enclosing of the lancet tape 3 is shown, the sealing process being achieved before the cutting process for making the individual label 1. Here, a substantially continuous foil 5 may be used to cover the two sides of the substrate 3a and the lancet 2. In FIG. 4, only one foil 5 is used to cover both sides of the substrate 3a, and the two foil portions 5a and 5b are foil 5 at the front edge 11 of the substrate 3a. ) Overlap in the third part 5c constituted by the part.

4A shows that the lancet 2 is in its cavity 10 before the sealing process or optionally after the hot sealing process. In both cases, the foil 5 constitutes a portion 5c which is superposed on each of the edges 10d and 11 of the substrate 3a. This overlapping part 6 is closed after the sealing process because the hot sealing process cannot reach the overlapping part in the form of the third part 5c in front of the lancet tip 2a. Constitute the risk of loosening the enclosure. This is a result of the dimensions of the hot sealing stamp, which cannot be adjusted to small dimensions, such as laser sealing lines.

4B shows the lancet 2 after the laser sealing process. It can be seen that the foil 5 is welded to the substrate 3a without constituting the portion overlapped by the edge 10d of the substrate 3a. Here, the sealing line coincides with the edge 10d of the substrate 3a. Compared to the closed covering of the lancet 2 of FIG. 4A, in FIG. 4B, the overlapping portion 6 of the foil 5 is the substrate 3a when the lancet 2 is sealed by a different sealing process such as hot sealing. Surround edges 3b and 3c).

5 and 5a, 5b show the cutting and sealing process of the lancet label 1 in a continuous process. FIG. 5A shows a metal sheet having a lancet structure made by, for example, an etching process or other processes known in the art such as cutting by a laser beam or stamping. In addition to the lancet structure 2, the metal sheet also has a positioning hole 57 at a defined position relative to the lancet. As above, the lancet is cut in the metal sheet but is still connected to the metal sheet, for example by at least one predetermined breaking point 58 at the rear end of the lancet body. As described below, when the lancet is disposed on the foil to constitute the lancet tape 3 as shown in Fig. 5, this breaking point is broken. As shown in Figs. 5B to 5D, the metal sheet is now disposed on the foil 51A to constitute the lancet tape 3 as shown in Fig. 5. Preferably, foil 51A is made of plastic, for example PET foil, which is self-adhesive. In particular, the foil is disposed under the matrix 101 including the fins 58 used to position the metal sheet 56 in a relatively defined manner relative to the matrix 101. Therefore, the positioning holes 57 of the metal sheet are adapted to the surface structure of the matrix 101 and allow the metal sheet to be positioned and fixed in the matrix and thus to be positioned and fixed relative to the foil 51A. . The matrix also has a cut 102 which positions the lancet directly inside and thus directly onto the plastic foil 51a. The stamp 100 now presses the lancet downwards on the plastic foil 51a as shown in FIGS. 5C and 5D, so that first part of the lancet is only in contact with the plastic foil, for example by a hot melting process. It is pre-fixed to the plastic foil. At the same time or after that, the predetermined breaking point is broken so that the lancet is separated from the metal sheet. The stamp 100 preferably has an inclined surface 101 in contact with the lancet such that the lancet tip first contacts the foil. Thereafter, the entire lancet is pressed into the foil by the stamp and fixed therein. Preferably, the foil 51A is disposed on the elastic support member 59 so that the pressure acting on the lancet by the stamp cannot damage the lancet. Such elastic support member may be constructed from elastic layer 59A covered by thin steel layer 59B. Preferably, the steel layer also has some cuts 59c through which the laser beam can be sent to fix the lancet to the foil via a hot melting process. Nevertheless, some known processes are generally possible for securing the lancet to the foil 51A. It is also possible to temporarily hold the lancet at a defined position on the tape, for example by magnetic force, and then separate the lancet from the metal sheet. The lancet can then be permanently fixed as above. Preferably, the permanent fixation of the lancet to the tape can be separated by carrying out the pricking process. In particular, the connection is automatically broken during the pricking process when the lancet is accelerated by the drive unit. Optionally, the lancet can remain fixed to the tape during the pricking process. In particular, the rear end of the lancet body remains fixed to the tape and the tape can be moved with the lancet.

In addition, the lancet tape 3 may be composed of at least three layers of a transfer layer 51a, a transport layer 52 and a cover layer 53. These three layers 51a, 52, 53 may all belong to the same material and may be configured as foils. These layers may be fixed to each other by means of adhesives which glue the layers together. At least one of the layers constitutes a foil covering the lancet 2. The material of the foils may be different or may be the same material. First, the foils are made of the same material. The lancet 2 is integrated into the transfer layer 51a in which the carrier layer 52 is located below the transfer layer 51a and the cover layer 53 is located above the transfer layer 51a. The cover layer 53 is transferred by the roll 54 just before the laser cutting and sealing process of the lancet. After moving the cover layer 53, the laser 4 cuts the lancet label 1 in the transport layer 52, and a portion of the transport layer 52 remains in the transport layer 51a as a sealing foil and the lancet 2 ) Enclosed). This transfer layer 51a may now be placed in a sterilization process, in which the lancet 2 remains sterilized due to the sterilized and sealed lancet label 1.

This lancet label 1 may be transferred to another tape 60 by contacting the transfer layer 51a with the tape 60. This contact takes place only at the point of contact of the tape and the transfer layer 51a supplied between the two rolls 61 and 62. In the region where the lancet label 1 is located in the transfer layer 51a as shown in FIG. 6, the adhesion to the tape 60 of the lancet label 1 is greater than the adhesion to the transfer layer 51a. In order to facilitate this transfer process, the tape 60 incorporates areas of sticking property or is covered with a sticky material or material in which the foil of the lancet label 2 is sticking. This contact of the tape 60 to the lancet label 2 is realized by a roller. The roller consists of two rolls 61 and 62 which can be pressed against each other in a controlled manner. The tape 60 and the transfer layer 51a are supplied between these two rolls. The roll 61 moves the transfer layer 51a and the roll 62 moves the tape 60. Transfer of the lancet label 1 from the transfer layer 51a to the tape 60 by varying the pressure between the two rolls 61 and 62 and by moving the rolls 61 and 62 at different speeds. The place may change.

Referring to FIG. 7, after the lancet assembly 22 is formed, the lancet assembly 22 may be packaged inside the foil 24. As will be appreciated from the description below, the lancet assembly 22 may be packaged in the foil 24 before, during or after sterilization, the lancet assembly 22 is sterilized. In the described embodiment, the foil 24 is a sheet of metal foil, and in other embodiments, the foil 24 is made of plastic. It should be appreciated that the foil 24 can be made of other types of materials. During manufacture, as shown in FIG. 7, the foil 24 is folded into two foil portions 40 with pleats or folds 42 therebetween. After folding, the lancet assembly 22 is sandwiched between the two folds 40 so that the pleats 42 close the cavity opening 34 of the cavity 31 of the lancet assembly 22. The foil portion 40 is fixed to the opposite (flat) side of the lancet assembly 22 so that the lancet 30 is sealed inside the cavity 31 by the cavity opening 34 sealed by the pleats 42. In one form, an adhesive is used to fix the foil to the guide member 28. Since the adhesive is applied to the guide member 28 around the cavity 31, but not to the lancet 30, the lancet 30 can continue to slide inside the cavity 31. Although the adhesive is used in the described embodiment, the foil 24 may be sealed with the guide member 28 in other ways such as heat sealing. In the described embodiment, the edges of the foil portion 40 are not sealed together, but in other embodiments the edges of the foil 24 can be sealed together to form a pocket covering the entire lancet assembly 22. In another embodiment, instead of folding the foil 24, the two foils 24 are joined together with the lancet assembly 22 sandwiched therebetween.

As will be explained, in one embodiment the integrated lancing test element 20 is formed in a continuous process. In a continuous process, the foil 24 is a continuous band of the lancet assembly 22 or a continuous band that is folded around the belt, which is unwound from the reel and likewise unwound from the reel. The lancet assembly 22 is sealed between the foil portions 40 of the foil 24, and the test element 26 is attached to the sheet 24 in the same manner as above. Foil 24 is combined with adjacent lancet integrated test element (LIT) unit 20 to form a continuous LIT tape 19 together. Between the individual units 20, the foil 24 has a fold or weakened line 43 that allows the tape 19 to be folded in a fan-fold fashion for storage. The fold line 43 can also be configured such that the individual units 20 can be separated from each other. Foil 24 may be weakened at fold line 43 in any number of ways known to those skilled in the art. For example, the sheet 24 may be bent or thinned at the fold line 43, and the fold line 43 may be continuous or discontinuous. The fold line 43 can be formed before or after the lancet assembly 22 is covered by the foil 24. In other embodiments, fold line 43 may be optional such that tape 19 folds naturally in a folded pan or other form.

In a preferred embodiment, this fold line is cut by the laser when the LIT unit is to be unified.

Once joined together, the lancet assembly 22 and the foil 24 form a lancet package or packet 44. As above, the lancet assembly 22 may be sterilized before or after being wrapped in the foil 24. The lancet assembly 22 can be sterilized through any number of sterilization techniques known to some of the well-known art, such as chemical, thermal, and / or radiation sterilization techniques. It should be understood that all or part of the lancet assembly 22 may be sterilized. For example, if desired, only lancet 30 and cavity 31 can be sterilized. In another embodiment, the lancet assembly 22 is sterilized after the lancet assembly 22 is packaged inside the lancet package 44. In one form, once the lancet 30 is covered by the foil 24, a radiation sterilization technique is used. In the lancet package 44 state, sterilization of the lancet assembly 22 can be carried out in a state where the test element 26 is not exposed to the undesirable effect of lancet sterilization. As a result, very specific calibration data can be ensured before the lancet package 44 is attached to the test element.

In the embodiment shown, test element 26 is an electrochemical type of test element. In one particular form, test element 26 is ACCU-CHEK ^? Although a modified version of the brand test element (Roche Diagnostics GmbH) is included, other types of test elements can be used. For example, in other embodiments test element 26 may include an optical type of test element or otherwise analyze a fluid sample. At one end, the test element 26 of the illustrated embodiment includes a connection 46 having an electrical contact 47 for delivering a sample record to the device. Opposite to the connection 46, the test element 26 has a capillary channel 48 having a capillary opening 49 configured to suck a body fluid sample through capillary action from the incision made by the lancet 30. . As is known, test element 26 includes an analysis region including an electrode, such as a working electrode, a counter electrode and a reference electrode, inside a capillary channel 48, and a reagent for analyzing a fluid sample. In one form, the connection 46 is connected to the instrument and the sample record from the electrode of the analysis region is transferred to the instrument via the electrical contact.

As briefly described above, a sterile lancet package 44 is attached to the test element 26 to form an integrated lancing test element unit 20. As described, the lancet package 44 is attached to the end of the test element 26 close to the capillary opening 49 of the capillary channel 48. In particular, since the cavity opening 34 of the lancet assembly 22 and the capillary opening 49 of the test element are located close to each other in a side by side relationship, the capillary channel opening 49 is very large when the lancet 30 forms an incision. Located in close proximity to collect fluid. The test element 26 is attached to the outside of the foil 24 covering the lancing member 22 to complete the integrated test element 20. While test element 26 is attached to lancet package 44 via adhesive in one form, it should be appreciated that test element 26 and lancet package 44 may be attached in other ways. In one form, the lancet package 44 is attached to the test element 26 such that its end edge is aligned with the end edge of the test element 26. However, in other embodiments, the edges of the lancet package 44 and the test element 26 may be offset from each other. For example, the edge of the lancet package 44 of the illustrated embodiment in the form of a third portion 42 as defined by the corrugation slightly enters from the edge of the test element 26 at the capillary opening 49. By allowing the lancet package 44 to enter, the fluid flow to the capillary channel opening 49 is promoted. In another example, foil 24 is positioned such that pleats 42 extend past the edge of test element 42. In this example, all or part of foil 24 may be hydrophobic and / or hydrophilic to direct fluid flow to capillary channel 48. In one particular form, foil 24 extends from test element 26 such that foil 24 acts as a flexible wicking flag that draws fluid into capillary channel 48.

In order to draw the body fluid towards the capillary channel opening 49 and away from the lancet 30, the test element 26 has a fluid direction notch facing the lancet package 44 in the illustrated embodiment. To enhance fluid flow towards the capillary channel opening 49, the foil 24 can be treated to be hydrophobic and / or made hydrophobic. If the foil 24 is hydrophobic, the foil can steal or wipe body fluids from the lancet 30 when the lancet 30 returns to the cavity 31. The wiping action of the foil 24 is believed to increase the amount of body fluid that can be used for sampling and make the lancet 30 cleaner for disposal. As above, with the lancet 30 sealed in the lancet package 44, the risk of cross contamination between the lancet 30 and the test element 26 is reduced.

In FIG. 7, test element 26 further defines a relief slot 51, through which the blade tip of the cam arm extends through the safety slot when engaging the lancet 30 during loading and firing. . In addition, the safety slot 51 can be used to evacuate air from the capillary channel 48 when the fluid is collected. The length of the safety slot 51 is generally similar to the length of the lancing stroke of the launch mechanism used to drive the lancet 30. When the lancet package 44 is attached to the test element 26, the engagement notch of the lancet 30 is aligned with the safety slot 51 of the test element 26. U.S. As described in more detail in patent application 2006/0200045, the blade tip of the cam arm for the launch mechanism extends through the engagement notch 39 of the lancet 30 and into the safety slot 51. When this happens, the blade tip pierces the foil 24. During lancing, the cam arm extends through the blade and draws the lancet 30 relative to the test element 26. When the lancet 30 is extended, the tip of the lancet 30 penetrates the foil 24 at the pleats 42. In one form, the foil 24 is weakened in the pleats 42 to assist in the perforation by the lancet 30, while in other forms the pleats 42 are not weakened. Once the lancet 30 is drawn into the cavity 31, the two foil portions 40 of the foil 24 can support the lancet 30 through friction. Coupling the lancet 30 in this manner reduces the risk of accidental perforation by the integrated lancing test element 22, because it is more difficult to drive the lancet 30 by hand and / or accidentally. It should be appreciated that the lancet assembly 22 can incorporate other structures to join the lancet 30. For example, the engagement notch 39 of the lancet 30 can be replaced with a protrusion or knob. In addition, the lancet can be fired through non-mechanical and / or contactless techniques that do not require perforation of the foil 24. By way of example, the lancet 30 is magnetically stored and fired through a voice coil driver or other magnetic driver in another embodiment. Since the lancet 30 is covered with the foil 24 both before and after the lancing, the risk of contamination is reduced and the risk of accidental wounds is likewise reduced.

Claims (32)

Providing a metal sheet in which a plurality of lancets comprising a lancet tip and a lancet body are fixed through at least one predetermined breaking point,
Positioning the metal sheet relative to the tape comprising at least one foil covering at least the lancet tip,
Placing at least one lancet on the tape and pressing the at least one lancet to the tape so that at least one break point is broken and the lancet is no longer connected with the metal sheet,
Before, at the same time or after fixing the lancet to the tape,
Removing the metal sheet,
Covering at least the lancet tip with a foil constituting at least partially overlapping first and second portions folded around the lancet tip to cover the lancet tip,
Without applying the sealing process in the region of the lancet tip so that the region of the foil through which the needle passes during the pricking process does not have a welded seam, at least one foil at least at the edges of the first and second portions of the overlapping portion A process of making a packaged lancet, comprising the step of sealing. The process of claim 1, wherein the sealing step comprises sealing with a laser beam. Providing a tape comprising a plurality of lancets comprising a lancet tip and a lancet body,
Covering at least the lancet tip with at least one foil constituting a first portion and a second portion folded at least partially over the lancet tip to cover the lancet tip,
Applying a force to the foil so that the foil is pressed in the first direction by the first component of the force and also in the second direction perpendicular to the first direction by the second component of the force, thereby providing a first portion of the foil and Superimposing the second portion and flattening the at least one portion of the foil towards the end of the lancet opposite the lancet tip,
Without applying the sealing process in the region of the lancet tip so that the region of the foil through which the needle passes during the pricking process does not have a welded seam, at least one foil at least at the edges of the first and second portions of the overlapping portion A process of making a packaged lancet, comprising the step of sealing. 4. The process of claim 3 wherein said sealing comprises sealing with a laser beam. 4. The process of claim 1 or 3, wherein one foil covers the first side of the lancet and the second foil covers the second side of the lancet. 4. The lancet according to claim 1 or 3, wherein the first portion of the foil covers the first side of the lancet, the second portion of the foil covers the second side of the lancet, and the first and second portions are lancet tips. Process of manufacturing a packaged lancet, connected by a third portion in front of. 4. A process according to claim 1 or 3, wherein the sealing of the foil is achieved by a layered laser sealing process. 4. A process according to claim 1 or 3, wherein the tape is cut by a laser to separate the lancet. The process of claim 8 wherein the sealing of the foil is achieved by a laser when the tape is cut by the laser. The process for making a packaged lancet according to claim 8, wherein different energy ratios are used for sealing and cutting the lancet. The process of claim 1, wherein the tape consists of a polymer. The process of claim 11, wherein the polymer is polyester. 4. The process of claim 1 or 3, comprising the further step of sterilizing the lancet. The process of claim 1, wherein the lancet body is attached to a test element. A lancet having a lancet tip and a lancet body, and
At least one foil constituting a first portion and a second portion folded at least partially over the lancet tip to cover at least the lancet tip,
After the foil covers at least a portion of the lancet, the two parts of the at least one foil without applying the sealing process in the region of the lancet tip such that the area of the foil through which the needle passes during the pricking process does not have a welded seam. A device for collecting body fluid, which is sealed by treating at least the edge constituted by the overlaid portion to maintain at least the lancet tip in a closed environment. The apparatus of claim 15, wherein the foil is sealed with a laser. The apparatus of claim 15, wherein the first portion and the second portion consist of two foils. The apparatus of claim 15, wherein the two portions are connected by a third portion in front of the tip of the lancet. 19. The apparatus of any of claims 15 to 18, wherein different regions of the foil are treated with different energies of the laser. 19. The device of any of claims 15 to 18, wherein the device also incorporates a test element. 19. The device of any of claims 15 to 18, wherein the lancet is movable in foil. The apparatus of claim 15, wherein the foil is constructed from a polymer material capable of absorbing energy from the laser beam. 19. An apparatus for collecting body fluid according to any one of claims 15 to 18, wherein the foil consists of one or more of the following materials:
·Polyester
Polypropylene
Polyethylene
Cyclic polyolefin
Polymethyl methacrylate
Polyvinylacetate
Polyamide 19. The device of any of claims 15 to 18, wherein the laser is one of the following:
Nd: YAG
CO ₂
Diode laser
Fiber laser 19. The apparatus of any of claims 15 to 18, wherein the lancet is driven by a driver. 27. The device of claim 25, wherein the lancet penetrates the foil when driven. 16. The apparatus for collecting body fluid according to claim 15, wherein the area of the foil in front of the lancet tip passing when the lancet is driven for execution of the pricking process does not have a welded seam. A process for the preparation of an apparatus for analyzing a component of a bodily fluid, comprising the lancet according to claim 15, wherein the lancet is combined with a test element comprising a bodily fluid application field before or after sealing the apparatus. 4. The process of claim 3 wherein the force is applied by an air brusher. 4. The process of claim 3 wherein the force is applied at a defined angle relative to the lancet tape. 31. The process of claim 30, wherein the angle is adjustable. 32. The process of claim 31 wherein the angle is adjustable as a function of air pressure.

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